Catalog Number

80-0900P4K

Brand Name

SPOTCHECK

Version/Model Number

80-0900P4K

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090940

Product Code

JJT

Product Code Name

Enzyme Controls (Assayed And Unassayed)

Public Device Record Key

9411bc55-31a0-47d5-b6bf-de7381e8969c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-